Al-Batran et al BJC 2010; O’Brien et al Ann Oncol 2004
•
Anthracycline rechallenge using PLD is effective in MBC pts who have a favourable PS, regardless of
setting, resistance, cumulative dose or time since prior conventional anthras therapy (
Al-Batran
pooled analysis, overall CBR 37%
)
Reduced cardiotoxicity & comparable efficacy with liposomal vs
conventional doxorubicin
•
Multicenter phase III RCT: PLD
50
q 28d vs doxorubicin
60
q21d
•
1L MBC, but prior HT and adjuvant CT allowed up to 15% (N=509)
•
Primary endpoint: PFS/cardiac toxicity
non-inferiority
(secondary: OS, ORR, tolerability and health
care use)
PFS
HR 1.00 (95% CI for HR 0.82– 1.22)
OS
HR 0.94
(NS) median 21 vs 22 mo
Overall risk of cardiotoxicity higher
doxorubicin vs PLD (HR 3.16, p<0.001)
•
Doxo AEs:
alopecia (overall, 66% vs 20%; pronounced, 54%
versus 7%), nausea (53% vs 37%), vomiting (31% vs 19%) and
neutropenia (10% vs 4%)
•
PLD AEs:
EPP (48% vs 2%), stomatitis (22% vs 15%) and
mucositis (23% vs 13%)
